Using the Population as Guinea Pigs - The Psychiatric Side Effects of a Poorly Tested Drug

From CBS11 TV in Dallas/Fort Worth

The drug manufacturer and the FDA say they test new drugs on a few people and then release it to the masses.

But the masses may be upset to learn that the government and drug companies may be using the population as guinea pigs.

For example, Becky Moser of Dallas is one of 3 million people taking Chantix, the anti-smoking pill. She said it is helping her quit.

But soon after taking the pill, Becky said she began to have thoughts of suicide. That was not one of the symptoms on the warning label, she said.

But Pfizer, the manufacturer of Chantix, knew about the side effect. When clinical trials were conducted, it was listed as a rare, adverse reaction.

According to Pfizer, Chantix was tested on approximately 5,000 people before its U.S. release. Becky thinks "that’s not a lot of people."

The Washington D.C. watch dog group Public Citizen agrees. The group put Chantix on its worst pill list.

There is great concern that new drugs have potential dangers that turn up after wide public release. According to Public Citizen, "one half of all problems that arise in a drug occur within the first 7 years."

According to Dallas psychiatrist Stephen Vobach, who researched drugs for clinical trials, that's just the way it's done.

In fact, traditionally drug companies, not the FDA, fund and conduct the drug research. The FDA does review the results, but some argue the pharmaceutical companies are better equipped to conduct the studies.

According to Pfizer, the clinical trial information is intended for doctors, not patients. That's why Becky didn't know that suicidal thoughts were an adverse reaction.

Pfizer points out "these aren't reactions associated with the drug, and there is no causal association - it's just that they were reported in the trials."

An official statement from Pfizer read:

Quitting smoking with or without treatment is associated with nicotine withdrawal symptoms such as depressed mood and anxiety. Quitting smoking has also been associated with the exacerbation of underlying psychiatric illness. Care should be taken with patients with a history of psychiatric illness and patients should be advised accordingly by their doctor.

It was a CBS 11 investigation last month that documented the bizarre behavior of Dallas musician Carter Albrecht who was shot and killed trying to break into a house. According to his family, it was just hours after taking Chantix with alcohol. Click here to read the investigation.

Since then, CBS 11 has received similar stories of rage and suicidal thoughts from people using Chantix. Click here to read some of their testimonials.

According to the FDA's database, the list of people complaining about the drug's side effects is nearly equivalent to the number of people who were part of its initial clinical trials.

Becky says if she knew then what she knows now, "I wouldn't have taken it."

Pfizer says Chantix is safe. It spends billions of dollars on research and is continuing to study the drug.